FDA.reportPublic FDA data

LUNIT INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30212307773021230777LUNIT INC.1N2027-01-014-8F, 374, Gangnam-daero, Gangnam-gu Seoul KR 06241

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3005801602890858K260320Lunit INSIGHT MMG (v1.1.10)QDQ2026-04-23
3005801857522430K253796Lunit INSIGHT DBT (V1.2)QDQ2026-03-26
3005801005884959K242652Lunit INSIGHT DBT v1.1QDQ2024-10-04
3005801011360573K231470Lunit INSIGHT DBTQDQ2023-11-06
3005801089538935K211733Lunit INSIGHT CXR TriageQFM2021-11-10
3005801563445143K211678Lunit INSIGHT MMGQDQ2021-11-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QDQ52026-04-23
QFM12021-11-10

PMN#

GUDID#